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Building on Needle Exchange to Optimize Prevention & Treatment

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ClinicalTrials.gov Identifier: NCT03567174
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : July 1, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Baltimore City Health Department
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
There are several biomedical interventions that can help people who inject drugs (particularly those with or at risk for HIV), but these services often do not get to the people most in need. In this project investigators propose to determine if delivery of these services to PWID by an integrated care van that is linked to a mobile syringe service program improves clinical outcomes, is feasible and sustainable, and is cost-effective.

Condition or disease Intervention/treatment Phase
Intravenous Drug Usage HIV/AIDS Other: Integrated care van (ICV) Not Applicable

Detailed Description:
Biomedical interventions that have direct applicability to people who inject drugs (PWID) have flourished over the past 15 years (HIV treatment as prevention, pre-exposure prophylaxis, office-based medication-assisted treatment (MAT) with buprenorphine, and hepatitis C virus (HCV) treatment with direct acting agents). However, penetration of these interventions among PWID is low relative to the potential benefits. Syringe service programs (SSP) are an essential risk reduction service for PWID, and represent the outermost reach of public health services for this population. The Baltimore City Health Department (BCHD) and investigators at Johns Hopkins University are developing a dedicated integrated care van (ICV) to complement the city's mobile SSP, with the goals of optimizing the HIV care cascade in HIV-positive clients and extending needed biomedical interventions to PWID. A nurse practitioner, case worker, and peer navigators will engage HIV-positive clients (known and newly diagnosed) and collaborate closely with local HIV clinics to promote progress toward durable viral suppression. To support the ICV's role in HIV care facilitation, investigators propose an innovative application of the Center for Disease Control (CDC)-sponsored "Data to Care" initiative - a multi-source health service database designed to assist health departments track the HIV care cascade in real time. Additionally, the ICV will provide rapid HIV testing, PrEP screening and initiation, buprenorphine-based MAT, HCV testing and referrals to treatment, and wound care. Using a cluster-randomized trial design, investigators propose to determine whether the ICV intervention advances the HIV care cascade among HIV-positive PWID, improves the Pre-Exposure Prophylaxis (PrEP) continuum, and increases uptake of MAT and HCV treatment (Aim 1). Additionally, investigators will examine the implementation of the ICV intervention using a mixed methods approach among PWID, local/state public health stakeholders, and medical providers to examine the intervention's feasibility, acceptability, coverage, fidelity, and sustainability (Aim 2). Finally, investigators will determine the incremental cost-effectiveness of the ICV intervention (Aim 3). Investigators have assembled a multi-disciplinary team with methodological expertise in PWID interventions and cost-effectiveness evaluations, and longstanding collaboration with investigators' partners at the BCHD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Building on Needle Exchange to Optimize Prevention & Treatment
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Integrated care van (ICV)
ICV visits neighborhoods served by the mobile syringe service program weekly. ICV provides a range of services targeted to people who inject drugs - HIV testing, HCV testing, PrEP, MAT, wound care, case work services, on-site medical management and linkage.
Other: Integrated care van (ICV)
Structural service delivery intervention

No Intervention: Control
No additional services provided.



Primary Outcome Measures :
  1. Composite PWID risk/service score [ Time Frame: Prior 6 months ]

    To capture the multifaceted nature of the ICV intervention and the array of health issues relevant to PWID, we developed a scoring rubric based on World Health Organization guidelines for evidence-based PWID services, a predictive risk model for HIV seroconversion among PWID developed by the Baltimore-based ALIVE study, the HCV care continuum, and the overdose epidemic. In the scoring rubric, points are allocated on the basis of riskier behaviors or health status (e.g., needle sharing, poorly controlled HIV) or for failing to use evidence-based services (e.g.,syringe service program, opioid substitution therapy, HCV testing).

    This outcome will be assessed in all participants at all time points. The score is based on self-report, biomarker testing, and medical record review, and ranges from 0 to 18, with higher scores indicating higher risk and lower utilization of services (worse overall status).


  2. HIV care cascade status [ Time Frame: Prior 6 months ]

    This outcome will be assessed in HIV-positive participants at all time points. The score is based on self-report, biomarker testing, and medical record review, and ranges from 0 to 3, with higher scores indicating poorer HIV care engagement.

    Participants with viral load suppression (HIV RNA <20 c/mL) score=0; those with non-suppressed viral load but detectable antiretroviral drugs in serum score=1; those with non-suppressed viral load, no detectable antiretroviral drugs, but a documented visit with an HIV provider in the prior 6 months score=2; those with non-suppressed viral load, no detectable antiretroviral drugs and no visit with an HIV provider in the prior 6 months score=3 .



Secondary Outcome Measures :
  1. PrEP continuum score [ Time Frame: Prior 6 months ]

    This outcome will be assessed in HIV-negative participants at all time points. The score is based on self-report, biomarker testing, and medical record review, and ranges from 0 to 2, with higher scores indicating poorer engagement with PrEP.

    Participants who are receiving PrEP and have detectable tenofovir on dried blood spot score=0; those who have no detectable tenofovir but who have been evaluated or treated with PrEP in the past score=1; those who have never been evaluated for PrEP or treated with PrEP score=2.


  2. Engagement in MAT [ Time Frame: Prior 6 months ]

    This outcome will be assessed in all participants at all time points. The score is based on self-report and medical record review, and ranges from 0 to 1.

    Participants who have not received MAT score 0; those who have received MAT score 1.


  3. HCV care continuum score [ Time Frame: Prior 6 months ]

    This outcome will be assessed in HCV-positive participants at all time points. The score is based on self-report, biomarker testing, and medical record review, and ranges from 0 to 3, with higher scores indicating poorer engagement with HCV care.

    Participants successfully treated for HCV with undetectable HCV RNA score=0; those who have a detectable HCV RNA but who have been evaluated or treated for HCV score=1; those who have a detectable HCV RNA, have never been evaluated or treated for HCV, but are aware of their HCV status score=2; those who have a detectable HCV RNA, have never been evaluated or treated for HCV, and are not aware of their HCV status score=3.


  4. Possession of naloxone overdose kit [ Time Frame: Prior 6 months ]

    This outcome will be assessed in all participants at all time points. The score is based on self-report, and ranges from 0 to 1.

    Participants who do not possess a naloxone overdose kit that is in an accessible location (i.e, where they usually use drugs) score=0; those who possess a naloxone overdose kit that is usually accessible when they use drugs score=1.


  5. Non-fatal overdose [ Time Frame: Prior 6 months ]

    This outcome will be assessed in all participants at all time points. The score is based on self-report, and ranges from 0 to 1.

    Participants who do not report a non-fatal drug overdose score=0; those who report a non-fatal drug overdose score=1.


  6. Use of emergency medical services [ Time Frame: Prior 6 months ]

    This outcome will be assessed in all participants at all time points. The score is based on self-report, and ranges from 0 to 2, with higher scores indicating more utilization of emergency services.

    Participants with no emergency department (ED) visits score=0, those with 1 ED visit score=1, those with 2 or more ED visits score=2.


  7. Mortality [ Time Frame: 12 months ]

    This outcome will be assessed in all participants at all follow-up time points. The score is based on medical record review or death certificate, and ranges from 0 to 1.

    Participants who are alive score=0, those who have died score=1.


  8. Qualitative assessments [ Time Frame: 12 months ]
    To provide context to our study and identify facilitators and barriers to the intervention, we will conduct qualitative assessments. First, we will conduct in-depth interviews (IDIs) with ~ 30 PWID participants. The interview will explore accessibility, coverage, and barriers accessing the services in question. Second, we will conduct IDIs with Baltimore City Health Department (BCHD) staff who work on either the existing SSP van or the newly created ICV (N~12). The interview will explore feasibility, perceived benefits and challenges of offering services in the field, and changes in perceptions after intervention roll-out on the ICV. Third, we will conduct IDIs with BCHD and Maryland Department of Health and Mental Hygiene (DHMH) officials and managers who are involved in PWID services (N~10). The interview will explore feasibility, and perceived benefits and challenges of offering services in the field on the ICV. We will digitally record the interviews.

  9. Costs and cost effectiveness [ Time Frame: 12 months ]
    In accordance with the recommendations of the 2nd US Panel on Cost-Effectiveness in Heath and Medicine, we will: inventory and value the resources consumed in the ICV intervention; estimate intervention effectiveness in regards to viral suppression, HIV infections averted, HCV treatment, and MAT use; estimate treatment costs averted and Quality-adjusted life years saved for each type of effectiveness; and determine whether the ICV is cost-saving, cost-effective, or not cost-effective.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • If HIV-positive: report history of injection drug use
  • If HIV-negative: injected drugs ≥ 4 days in the last 30 days or shared a needle or syringe in the last 6 months

Exclusion Criteria:

  • Not competent to provide written informed consent
  • Not willing or able to provide a blood specimen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567174


Contacts
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Contact: Katie Zook 410-614-2938 kcook7@jhmi.edu
Contact: Donald Brown 410-502-9520 dbrow140@jhmi.edu

Locations
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United States, Maryland
Baltimore City Syringe Service Program Neighborhood sites Recruiting
Baltimore, Maryland, United States, 21205
Contact: Katie Zook    410-614-2938    kcook7@jhmi.edu   
Contact: Donald Brown    410-502-9520      
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Baltimore City Health Department
Investigators
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Principal Investigator: Gregory M Lucas, MD Johns Hopkins University
Principal Investigator: Kathleen Page, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03567174     History of Changes
Other Study ID Numbers: IRB00147873
R01DA045556 ( U.S. NIH Grant/Contract )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Willing to share de-identified Individual Participant Data (IPD) with researchers that approach our team with an acceptable proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
hepatitis C